FDA recall Z-2554-2025

SEASPINE ORTHOPEDICS CORPORATION · Class II · device

Product

Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

Reason for recall

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

Distribution

Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.

Key facts

Status
Ongoing
Initiation date
2025-08-06
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2554-2025